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Effect of Meal Frequency on Diet Self-Efficacy and Perceived Stress in Women With Weight Cycling

8 de mayo de 2026 actualizado por: İlknur Gökçe YILDIRIM=, Ankara Medipol University

Effect of a Diet Intervention With Different Meal Frequencies on Diet Self-Efficacy and Perceived Stress in Women With Weight Cycling: A Randomized Controlled Trial

The World Health Organization (WHO) defines obesity as abnormal or excessive fat accumulation in the body that may adversely affect health. In 2022, 1 in 8 people worldwide lived with obesity, while the adult obesity rate has more than doubled since 1990, and the adolescent obesity rate has quadrupled.

Obesity is a risk factor for noncommunicable diseases such as type 2 diabetes, hypertension, cardiovascular diseases, cancer, and sleep apnea, and is associated with an increased risk of death. The treatment of obesity-related comorbidities, along with indirect costs resulting from lost productivity and premature death, contributes to the economic burden caused by obesity. Therefore, effective management of obesity is of critical importance for improving overall health outcomes and reducing the burden on healthcare systems. It has been demonstrated that a 5% reduction in body weight in individuals diagnosed with obesity can improve health outcomes, and this value has been established as a target standard for weight loss interventions. However, while dietary interventions can achieve clinically meaningful weight loss, weight regain is common due to a combination of low adherence to dietary strategies and compensatory physiological mechanisms that influence weight regain. Consequently, individuals may find themselves in a "weight cycle," losing weight and then regaining it. Weight maintenance is defined as intentional weight loss followed by the preservation of that loss for at least six months. It has been noted that the weight cycle complicates this process.

The weight cycle defined as repeated periods of intentional weight loss followed by regain is considered a common yet poorly understood factor among obese individuals. The weight cycle is viewed as one of the major challenges in clinical obesity care. For this reason, it is emphasized that strategies aimed at preventing weight cycling or promoting weight maintenance have gained importance. Additionally, attention is drawn to psychological factors in eating behavior, with particular emphasis on the individual's self-confidence and stress levels being crucial for sustaining healthy eating behaviors.

Individuals experiencing weight cycling often face challenges with diet adherence, sustainability, and stress management. Meal frequency strategies applied to these individuals can influence not only weight loss but also diet adherence and the psychological experience of the dietary process. Given the rise in obesity and obesity-related disorders, understanding the relationship between stress, self-efficacy, and food choice in young adulthood may offer insights into preventing adverse health outcomes in later life stemming from poor dietary habits. An appropriate meal schedule can help an individual adapt better to the diet and manage the process with less stress; thereby facilitating weight maintenance success and making healthy eating a lifestyle. However, in the treatment of obesity, data regarding different meal frequency approaches in dietary interventions remain controversial.

The aim of this study is to examine the factors influencing the sustainability of the diet and the long-term maintenance of weight loss in individuals experiencing weight cycling. In this context, the effects of different meal frequencies on this process were evaluated; the study addressed not only physical outcomes but also psychological factors such as how individuals felt during the dietary process, their stress levels, and their self-confidence. Thus, the aim was to present a more comprehensive perspective by examining the relationship between meal frequency and weight management from both physiological and psychological dimensions.

Descripción general del estudio

Descripción detallada

The study was conducted on women aged 25-55 who voluntarily applied to a dietary counseling office, met the inclusion criteria, had a BMI between 25 and 35 kg/m², and experienced weight fluctuations. In the analysis conducted to determine the sample size, the effect size was f = 0.204, the Type I error level was α = 0.05, the test power (1-β) was 0.95, and measurements were taken at 6 time points (0, 2, 4, 6, 8 Weeks and 6 months after the intervention ended), inter-measurement correlation r = 0.50, and the non-sphericity correction ε = 1. Under these conditions, the required total sample size was determined to be 41; considering the anticipated 20% participant attrition during the study, it was determined that at least 49 participants were needed, and to obtain more accurate data, it was planned to include at least 52 participants; the study was completed with a total of 59 participants. The intervention phase of the study lasted 8 weeks for each participant. During the intervention period, face-to-face interviews were conducted every 2 weeks, and all measurements within the scope of the study were repeated. Following the completion of the 8-week intervention, no further intervention or follow-up was conducted, and participants' ability to maintain their weight loss was assessed via a single follow-up measurement 6 months later. In accordance with the recommendations, a weight-loss diet was planned and implemented for each participant, reducing daily energy intake by 500-700 kcal to facilitate a weight loss of 0.5-1.0 kg per week; A weight-loss diet appropriate for the women's age and energy and nutrient requirements was planned, and two groups were formed using a simple randomization method. Group 1 followed a meal plan consisting of 3 main meals, while Group 2 followed a meal plan consisting of 3 main meals and 3 snacks. Written and verbal informed consent was obtained from all participants via the "Informed Consent Form." At the beginning of our study, a general information form, a three-day food consumption record, the International Physical Activity Questionnaire Short Form (IPAQ SHORT FORM), the Perceived Stress Scale (PSS), the Dietary Self-Efficacy Scale (DESS), and the General Well-Being Scale Short Form (GWBS-SF) were used. At the 8th week, when the intervention ended, and at the 6-month follow-up, the Perceived Stress Scale (PSS), Dietary Self-Efficacy Scale (DESS), and General Well-Being Scale Short Form (GWBS-SF) were repeated. Anthropometric measurements and body composition analyses conducted as part of the study (body weight, height, BMI, waist-to-height ratio, waist circumference, hip circumference, neck circumference, waist-to-height ratio waist-to-hip ratio, total body fat (kg and %), lean body mass (kg and %), body water (L ), basal metabolic rate (kcal)) were performed at weeks 0, 2, 4, 6, and 8, as well as 6 months after the intervention ended. Anthropometric measurements were taken using standard measurement techniques, while body composition analyses were performed using the INBODY 270 device. Anthropometric indices (Lipid Accumulation Product Index - LAP, Visceral Adiposity Index - VAI, Conicity Index - CI, Body Shape Index - ABSI, Abdominal Volume Index - AVI, Body Adiposity Index - BAI, Body Roundness Index - BRI, Anthropometric Risk Index - ARI) calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters. Participants' biochemical test results were used to develop individualized dietary plans and to observe changes in biochemical findings during the weight loss process. No new blood tests were requested from the participants in this study. The biochemical data used in the study (fasting blood glucose, triglycerides, total cholesterol, HDL-C, LDL-C, TSH, ALT, AST, HbA1c) were obtained from laboratory results recorded in the participants' health records and dating back to the past 3 months. Note: This trial was retrospectively registered. Data collection was completed prior to registration in ClinicalTrials.gov.

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Altındağ
      • Ankara, Altındağ, Turquía (Türkiye)
        • Ankara Medipol University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Female participants aged 25-55 years
  • Body mass index (BMI) between 25 and 35 kg/m²
  • having a history of weight fluctuations
  • Willingness to participate and provide informed consent

Exclusion Criteria:

  • Presence of cardiovascular disease
  • Chronic kidney disease
  • Hypertension
  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Pregnancy or breastfeeding
  • Use of any medication or dietary supplement for weight loss or fat reduction
  • Engagement in intense physical activity
  • No having a history of weight fluctuations
  • Menopausal status
  • Failure to attend scheduled follow-up visits
  • Non-adherence to the intervention protocol for three consecutive days

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 3 Meal Group
Participants followed a weight-loss diet consisting of 3 main meals per day.
A personalised weight-loss diet that reduces daily calorie intake by 500-700 kcal. Group 1 followed the diet for 8 weeks, consisting of 3 main meals a day.
Experimental: 6 Meal Group
Participants followed a weight-loss diet consisting of 3 main meals and 3 snacks per day.
A personalised weight-loss diet that reduces daily calorie intake by 500-700 kcal. Group 1 followed the diet for 8 weeks, consisting of 3 main meals and 3 snacks per day.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body weight (kg)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body weight measured using a calibrated digital scale
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body mass index (kg/m²)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Calculated as body weight in kilograms divided by height in metres squared
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Height (cm)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Height measured using a stadiometer with participants standing upright, feet together, in Frankfurt plane position.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Waist circumference (cm)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Waist circumference was measured using a non-stretch tape measure along the midline between the lowest rib and the iliac crest, with the individual standing with their feet together and arms at their sides in a relaxed position.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Hip circumference (cm)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Hip circumference was measured using a non-stretchable tape measure across the widest part of the hips, with the individual standing upright, feet together and arms at their sides
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Neck circumference (cm)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
During neck circumference measurements, participants were positioned upright with their arms at their sides and their feet together. The measurements were taken by the researcher, who stood opposite the participant, using a non-stretchable tape measure around the neck near the shoulder.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
waist-to-height ratio
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Waist-to-height ratio calculated by dividing waist circumference (cm) by height (cm).
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
waist-to-hip ratio
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Waist-to-hip ratio calculated by dividing waist circumference (cm) by hip circumference (cm).
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
basal metabolic rate (kcal)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body Fat mass (kg)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Lean body mass (kg)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Percentage of lean body mass(%)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Body fat percentage (%)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Total body water (L)
Periodo de tiempo: Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
The measurements were taken using bioelectrical impedance analysis (BIA) with the INBODY 270 device.
Baseline, Weeks 2, 4, 6, and 8, and 6 months post-intervention
Lipid accumulation product index-LAP
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference(cm) and triglycerides (mmol/L))
Baseline, Week 8 and 6 months post-intervention
Visceral adiposity index-VAI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (cm), body mass index(kg/m²),HDL-C (mmol/L) and triglycerides (mmol/L)).
Baseline, Week 8 and 6 months post-intervention
Conicity index - CI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (m),Body weight (kg), Height (m) )
Baseline, Week 8 and 6 months post-intervention
A body shape index-ABSI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (m), BMI(kg/m²) and heigh(m))
Baseline, Week 8 and 6 months post-intervention
Abdominal volume index-AVI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (waist circumference (cm), hip circumference (cm)).
Baseline, Week 8 and 6 months post-intervention
Body adiposity index-BAI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (Hip circumference (cm), Height (m)).
Baseline, Week 8 and 6 months post-intervention
Body roundness index-BRI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Calculated using validated formulas based on anthropometric measurements and relevant biochemical parameters (Waist circumference (m), Height (m)).
Baseline, Week 8 and 6 months post-intervention
Anthropometric risk index-ARI
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Anthropometric Risk Score (ARS) is a composite score calculated by scoring each anthropometric parameter (BMI, waist circumference, waist-to-hip ratio, and waist-to-height ratio) based on established reference cutoff values and summing the individual scores.
Baseline, Week 8 and 6 months post-intervention
Fasting blood glucose (mg/dL)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
Triglycerides (mg/dL)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
Total cholesterol (mg/dL)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
HDL cholesterol (mg/dL)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
LDL cholesterol (mg/dL)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
Thyroid stimulating hormone (TSH) (µIU/mL)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
Alanine aminotransferase (ALT) (U/L)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention
Aspartate aminotransferase (AST) (U/L)
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
No additional blood samples were collected from participants. Biochemical data were obtained from existing health records, reflecting results from the previous 3 months, measured after a minimum 8-hour fasting period using standard laboratory methods.
Baseline, Week 8 and 6 months post-intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
perceived stress level
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Assessed using the Perceived Stress Scale. Scores on the Perceived Stress Scale-14 range from 0 to 56, with a higher score indicating a greater perception of stress (a worse outcome). No cut-off point has been established for the scale.
Baseline, Week 8 and 6 months post-intervention
dietary self-efficacy
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Assessed using the Dietary Self-Efficacy Scale. Scores on the Dietary Self-Efficacy Scale range from 11 to 55, with a higher score indicating greater dietary self-efficacy (a better outcome). No cut-off point has been established for the scale.
Baseline, Week 8 and 6 months post-intervention
General Well-Being
Periodo de tiempo: Baseline, Week 8 and 6 months post-intervention
Assessed using the General Well-Being Scale Short Form. Scores on the General Well-being Scale Short Form range from 14 to 70, with a higher score indicating a higher level of well-being (a better outcome). No cut-off point has been established for the scale.
Baseline, Week 8 and 6 months post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Elif Dadak Yıldırım, PhD(c), Ankara Medipol University
  • Investigador principal: İlknur G Yıldırım, Asst. Prof., Ankara Medipol University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de agosto de 2025

Finalización primaria (Actual)

1 de octubre de 2025

Finalización del estudio (Actual)

1 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de mayo de 2026

Publicado por primera vez (Actual)

13 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared to protect participant privacy and confidentiality. All data were collected under informed consent with assurances of anonymity

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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